Device for and method of treating acromioclavicular joint dislocations

ABSTRACT

A device that allows for the predictable/guided anatomic drilling of clavicular tunnels for graft, suture, or combined graft/suture reconstruction of the AC joint is provided. The device simultaneously allows for larger clavicle tunnels which permit graft passage while providing protection, via stress shielding, of the bone between and adjacent to the bone tunnels. In this way, the surgeon is able to utilize anatomically placed clavicular tunnels large enough for graft passage (which reduces the mechanical failure rate of the reconstruction and most closely replicates normal anatomy) while reducing the risk of clavicle fracture, which has plagued other “anatomic reconstruction” techniques.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 16/020,691, filed Jun. 27, 2018, now U.S. Pat. No.11,141,205, which claims priority pursuant to 35 U.S.C. 119(e) to U.S.Provisional Patent Application Ser. No. 62/525,267, filed Jun. 27, 2017,the entire disclosures of which is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices. Morespecifically, the present invention is concerned with a clavicle platethat is configured to facilitate treatment of acromioclavicular jointdislocations.

BACKGROUND

Injuries to the acromioclavicular (AC) joint are very common. AC jointdislocations account for approximately 8% of all joint dislocations inthe body. The severity of the injury determines the most appropriatetreatment. Because the majority of the injuries occur in young athleticpopulations, the ability to restore function and provide predictablepain relief is critically important.

Fortunately, the anatomy of the coracoclavicular (CC) ligaments (Conoidand Trapezoid) and the AC joint capsule is well defined, as are theirroles in both normal and injured shoulders. Much work has been done todefine the biomechanical responsibilities of the Conoid and TrapezoidLigaments. These works have successfully provided surgeons with a clearunderstanding of both the topographical and biomechanicalcharacteristics of these ligaments. The different orientation of the twocomponents has proven to account for different functions. As ourunderstanding of these elements has improved, techniques designed toreconstruct injured CC ligaments have evolved and while many haveoffered hope and some have offered function, all have offeredunacceptably high complication rate.

There are over 60 different techniques described to treat AC jointdislocations. This abundance of techniques reflects the inability forany singular technique to be seen as the “gold standard”. Fueled by theseriousness of AC joint injuries, the effects AC joint injuries has onthose with them, and the high complication rates of previously knowntechniques, the orthopedic industry continues to strive to create a goldstandard technique for AC joint dislocation treatment.

In 1972, Drs. Weaver and Dunn first described a soft tissue basedprocedure to reconstruct the CC ligaments. Although this technique wasabandoned because of a high rate of graft failures and othercomplications, it laid the foundation for new techniques to bedeveloped. Unfortunately, previous attempts to eliminate suchcomplications, such as by more accurately replicating the nativeligaments with tendon grafts, has created additional complications, suchas an unacceptably high rate of bone fracture. For instance, toaccurately replicate the native ligaments with tendon grafts, two holesmust be drilled through the clavicle, with one hole being positionednear a posterior edge of the clavicle and the other hole beingpositioned closer to an anterior edge of the clavicle. Consequently, theoverall strength of the clavicle is weakened, increasing the risk ofclavicle fracture at either hole and/or between the holes.

Efforts to reduce the incidence of clavicle fractures in anatomic ACjoint reconstruction fail to resolve the initial complications. Forinstance, additional middle-ground techniques have been described whichallow smaller tunnels, or a singular tunnel to be utilized.Unfortunately, because these techniques do not adequately restore thenormal anatomy, they do not adequately restore normal tensions andstresses on the AC joint and subsequently they too have an unacceptablyhigh complications and/or failure rates.

Consequently, it would be beneficial to have a device for and/or amethod of replicating the native ligaments with tendon grafts and/orotherwise reducing complications associated with reconstruction of ACjoints while reducing the risk of clavicle fracture.

Clavicle plate and screw systems of the prior art are used to assistwith healing of clavicle fractures. Specifically, the clavicle platesare secured to the clavicle on each side of the fracture such that theplate spans the fracture, thereby replacing the structural rigidity ofthe clavicle that had been lost due to the fracture. Some such platesfurther provide features for coracoclavicular (CC) ligament support.Such ligament support, however, fails to accurately replicate the nativeligaments.

Previously known methods for accurately replicating native ligaments aretime consuming and labor intensive. For instance, extensive measurementsmust be taken and analyzed to determine how to replicate the nativeligaments. Upon obtaining precise measurements, a surgeon must utilizethis information to locate and orient a drill relative to a clavicle.Unfortunately, much of the precision of the measuring step can be lostin the drilling step, increasing associated risks. Furthermore, even ifthe drilling step is completed with perfect precision, the clavicle isleft weakened and vulnerable. Furthermore still, some techniques requirethe drilling step to drill oversized holes to accommodate screws, suchas interference screws, for anchoring or otherwise affixing suturesrelative to the clavicle, thereby further weakening the clavicle.Consequently, it would be beneficial to utilize a clavicle plate toreinforce the weakened clavicle. Furthermore, it would be beneficial ifthe clavicle plate was configured so as to assist the surgeon inlocating the plate onto the clavicle. Furthermore still, it would bebeneficial if the clavicle plate included one or more feature forassisting a surgeon in drilling one or more hole through the clavicle.Furthermore yet, it would be beneficial if precise measurements werebuilt into the configuration of the clavicle plate such that utilizationof the clavicle plate facilitates accurate replication of nativeligaments. Furthermore still, it would be beneficial if the clavicleplate included one or more feature for affixing sutures relative to theclavicle.

SUMMARY

The present invention comprises a device for and a method of treatingacromioclavicular (AC) joint dislocations. The device is a plate likedevice (a “clavicle plate” or a “plate”) which could be made of anyappropriate material. In some embodiments, the clavicle plate includesone or more positioning feature designed to allow the user to quicklyand easily determine the correct placement of the device. In some suchembodiments, the positioning feature is a mark, such as a centerline orother mark. In some embodiments, the location of the positioning featureon the clavicle plate is determined based on osteologic analysis ofhuman clavicles.

The clavicle plate defines two apertures, the first aperture beingassociated with an anatomical location of the native Conoid Ligament andthe second aperture being associated with an anatomical location of thenative Trapezoid Ligament. In this way, the spacing between the firstand second apertures represents the anatomic spacing between the nativeligaments.

In some embodiments, each aperture is configured to interface with anappropriate sized drill guide, thereby assisting the user in drillingrespective first and second holes through the clavicle. Each of thefirst and second holes (also referred to as bone tunnels) is configuredto allow for suture, graft, or combination suture/graft passage. Becausethe anatomic spacing between the native ligaments is replicated with theaperture spacing, it is also replicated with the drill hole spacing,thereby reducing complications associated with reconstruction of ACjoints.

Unlike other techniques, the present invention facilitatesperfect/anatomical placement of the clavicular bone tunnels withoutrequiring the end user to make “complex osteologic measurements” inorder to place the tunnels in the appropriate location. This is becausethe clavicle plate of the present invention has these complicatedmeasurements built into it.

The clavicle plate of the present invention is configured to beselectively secured to a clavicle of a patient. In this way, the firstand second apertures are capable of being retained in position relativeto the clavicle prior to a user drilling respective first and secondholes.

The present invention further includes methods of treating AC jointdislocations and other injuries associated with the clavicle, such as byusing the clavicle plate of the present invention to assist withdrilling, aligning, and/or supporting the clavicle. The presentinvention further includes methods of treating clavicle fractures andother injuries and/or problem areas associated with the clavicle, suchas by securing the clavicle plate of the present invention to a claviclesuch that the clavicle plate provides structural support to theclavicle, thereby allowing the clavicle to heal and/or to prevent damageto the clavicle.

The foregoing and other objects are intended to be illustrative of theinvention and are not meant in a limiting sense. Many possibleembodiments of the invention may be made and will be readily evidentupon a study of the following specification and accompanying drawingscomprising a part thereof. Various features and subcombinations ofinvention may be employed without reference to other features andsubcombinations. Other objects and advantages of this invention willbecome apparent from the following description taken in connection withthe accompanying drawings, wherein is set forth by way of illustrationand example, an embodiment of this invention and various featuresthereof.

BRIEF DESCRIPTION

A preferred embodiment of the invention, illustrative of the best modein which the applicant has contemplated applying the principles, is setforth in the following description and is shown in the drawings and isparticularly and distinctly pointed out and set forth in the appendedclaims.

FIG. 1 is a top plan view of a clavicle plate of the present inventionshowing different lengths in dashed lines.

FIG. 2A is a side elevation view of a tapered button of the presentinvention.

FIG. 2B is a bottom plan view of a tapered button of FIG. 2A.

FIG. 2C is a side elevation view of a drill guide that is configured tobe used with the clavicle plate of the present invention.

FIG. 2D is a bottom plan view of the drill guide of FIG. 2C.

FIG. 3A is a visual representation of a clavicle plate of the presentinvention being affixed to a clavicle of a patient and anchored to acoracoid of the patient.

FIG. 3B is a visual representation of a clavicle plate of the presentinvention being affixed to a clavicle of a patient, FIG. 3B furthershowing a tendon extending from the clavicle plate and wrapping around acoracoid of the patient, the tendon being secured to buttons associatedwith the clavicle plate.

FIG. 3C is a visual representation of a clavicle plate of the presentinvention being affixed to a clavicle of a patient, FIG. 3C furthershowing a tendon wrapping around the clavicle plate and a coracoid ofthe patient and a suture extending from the clavicle plate and wrappingaround the coracoid, the tendon extending through first and secondapertures of the plat and the ends of the suture extending into smallapertures of the plate.

FIG. 3D is a visual representation of a clavicle plate of the presentinvention being affixed to a clavicle of a patient, FIG. 3D furthershowing a suture extending from the clavicle plate and wrapping around acoracoid of the patient, first and second ends of the suture extendinginto respective first and second apertures of the clavicle plate.

DETAILED DESCRIPTION

As required, a detailed embodiment of the present invention is disclosedherein; however, it is to be understood that the disclosed embodiment ismerely exemplary of the principles of the invention, which may beembodied in various forms. Therefore, specific structural and functionaldetails disclosed herein are not to be interpreted as limiting, butmerely as a basis for the claims and as a representative basis forteaching one skilled in the art to variously employ the presentinvention in virtually any appropriately detailed structure.

Referring to FIGS. 1 and 3A, some embodiments of the clavicle plate 10include a main body 110 defining first 112 and second 114 fasteningfeatures, such as screw holes or the like, for securing the plate to aclavicle 20 of a patient. In some such embodiments, the first and secondfastening features are configured to receive or otherwise engage withrespective first 12 and second 14 fastening devices, such as locking ornon-locking screws, for clavicular fixation. In some embodiments, eachfastening device is a fastening screw having a diameter ranging from 3.5mm to 4.0 mm. In some embodiments, the first and second fasteningfeatures are defined by respective first portion 160 and second portion170 of the main body. In some embodiments, first portion 160 and secondportion 170 of the main body extend from opposed ends of a third portion180 of the main body. In some embodiments, each of the first and secondportions is configured to be secured to respective first and secondregions of a clavicle such that the third portion 180 of the main bodyspans a third region of the clavicle. In this way, the main body of theclavicle plate is configured to replace loss of structural integrity ofthe clavicle, such as through a break, a reduction of material (such asthrough the creation of one or more bone tunnel), or other reduction ofstructural integrity of the clavicle.

In some embodiments, the main body defines first 120 and second 140apertures. In some embodiments, each of the first and second aperturesis associated with an anatomical location of a ligament of the patient.In some embodiments, the first and second apertures of the clavicleplate are each defined by the third portion of the main body.

In some embodiments, the first and second apertures are configured forfacilitating the creation of bone tunnels and/or otherwise facilitatinggraft/suture passage through one or more bone tunnel. In someembodiments, the first and second apertures are configured to interfacewith appropriate sized drill guides 25, thereby assisting the user increation of respective first and second bone tunnels through theclavicle. In some such embodiments, the drill guide(s) and the firstand/or second apertures include corresponding interface features forpositioning and orienting the drill guide(s) relative to the clavicle,thereby facilitating the positioning and vectoring of the bone tunnels.In some embodiments, the main body is configured to interface with aplurality of drill guides and/or other devices now know or laterdeveloped, such as by way of the first and/or second aperture orotherwise.

In some embodiments, the main body defines one or more fixation feature115 for selective engagement with one or more fixation device 15, suchas sutures utilized in repair of surrounding soft tissue, therebyproviding potential fixation points for such fixation devices. In somesuch embodiments, one or more fixation feature comprises one or moresmall aperture.

In some embodiments, the first aperture is associated with a conoidligament of the patient. In some such embodiments, a second fixationfeature is positioned anterior to the first aperture.

In some embodiments, the second aperture is associated with a trapezoidligament of the patient. In some such embodiments, a first fixationfeature is positioned posterior to the second aperture. In someembodiments, the first 120 and/or second 140 apertures are configured toreceive a button 250. In some embodiments, the button and the firstand/or second apertures include corresponding interface features. Insome such embodiments, walls of the first and/or second aperture aretapered inward so as to define a bottom opening that is smaller than anopposed top opening. In some such embodiments, the button definescorresponding tapered side walls such that the button is capable ofbeing moved in and out of the first and/or second aperture through thetop opening but is incapable of passing through the bottom opening. Inthis way, the button is moveable to a seated configuration by moving thebutton in a first direction relative to the main body of the plate untilthe corresponding interface features prevents the button from moving anyfurther. In some embodiments, the button and main body are configuredsuch that biasing the button in a first direction while the first buttonis in a seated configuration prevents or otherwise inhibits the firstbutton from moving away from a seated configuration. In someembodiments, moving the first button in a second direction causes thefirst button to move from the seated configuration to an unseatedconfiguration.

In some embodiments, the button 250 defines one or more engagementfeature 252 so that it is capable of being utilized for graft/sutureplacement. In some such embodiments, the one or more engagement feature252 is a hole or pattern of holes, such as a pattern of four holes. Insome embodiments, the button is configured such that a top surface ofthe button is flush with a top surface of the main body when the buttonis seated in the first and/or second aperture. In some embodiments,first and second buttons are associated with respective first and secondapertures.

In some embodiments, the button is configured so as to allow a user tosecure one or more attachment member 50 to the main body. In someembodiments, the attachment member 50 can be sutures used for fixationand/or sutures sewn into tendon graft ends. In some embodiments, one ormore attachment member 50 obviates any requirements for interferencescrew placement.

In some embodiments, the button is configured so as to facilitatecoupling one or more attachment member 50 to the button, such as to anunder surface of the button. In some embodiments, drilling largerclavicle tunnels to can be avoided by passing attachment members, suchas sutures, from inferior to superior. In some such embodiments, thepresent invention enables the risk of clavicle fracture to be reduced byallowing for slightly smaller holes to be drilled if desired.

The present invention further includes a method of treating AC jointdislocations and other injuries associated with the clavicle by drillingbone tunnels through a third region of a clavicle of a patient, thethird region of the clavicle being positioned between opposed first andsecond regions of the clavicle. In some embodiments, the method includesutilizing one or more positioning feature 150 of the clavicle plate 10of the present invention to position the clavicle plate 10 relative tothe clavicle 20. In some embodiments, the method further includessecuring first and second portions of the clavicle plate to respectivefirst and second regions of the clavicle such that a third portion ofthe clavicle plate, extending between the first and second portions ofthe clavicle plate, extends over the third region of the clavicle. Inthis way, the clavicle plate provides structural support to theclavicle, thereby reducing risk of fracture associated with drillingbone tunnels through the third region of the clavicle. In someembodiments, the method includes securing to the clavicle plate suturesused for fixation and/or sutures sewn into tendon graft ends. In somesuch embodiments, buttons associated with first and/or second aperturesof the clavicle plate are utilized to assist with anchoring, wrapping,and/or grafting. In some embodiments, one or more fixation feature 115,such as a small aperture, is utilized to receive one or more fixationdevice 15, such as a suture. In some embodiments, a first and/or secondaperture is utilized without a button to assist with anchoring,wrapping, and/or grafting.

The present invention further includes a method of treating claviclefractures and other injuries associated with the clavicle by securingfirst and second portions of a clavicle plate of the present inventionto respective first and second regions of the clavicle such that a thirdportion of the clavicle plate, extending between the first and secondportions of the clavicle plate, extends over the fracture. In this way,the clavicle plate provides structural support to the clavicle, therebyallowing the clavicle to heal.

In the foregoing description, certain terms have been used for brevity,clearness and understanding; but no unnecessary limitations are to beimplied therefrom beyond the requirements of the prior art, because suchterms are used for descriptive purposes and are intended to be broadlyconstrued. Moreover, the description and illustration of the inventionsis by way of example, and the scope of the inventions is not limited tothe exact details shown or described.

Although the foregoing detailed description of the present invention hasbeen described by reference to an exemplary embodiment, and the bestmode contemplated for carrying out the present invention has been shownand described, it will be understood that certain changes, modificationor variations may be made in embodying the above invention, and in theconstruction thereof, other than those specifically set forth herein,may be achieved by those skilled in the art without departing from thespirit and scope of the invention, and that such changes, modificationor variations are to be considered as being within the overall scope ofthe present invention. Therefore, it is contemplated to cover thepresent invention and any and all changes, modifications, variations, orequivalents that fall with in the true spirit and scope of theunderlying principles disclosed and claimed herein. Consequently, thescope of the present invention is intended to be limited only by theattached claims, all matter contained in the above description and shownin the accompanying drawings shall be interpreted as illustrative andnot in a limiting sense.

Having now described the features, discoveries and principles of theinvention, the manner in which the invention is constructed and used,the characteristics of the construction, and advantageous, new anduseful results obtained; the new and useful structures, devices,elements, arrangements, parts and combinations, are set forth in theappended claims.

It is also to be understood that the following claims are intended tocover all of the generic and specific features of the invention hereindescribed, and all statements of the scope of the invention which, as amatter of language, might be said to fall therebetween.

What is claimed is:
 1. A clavicle plate for reinforcing a clavicle of apatient, the plate comprising: a main body having opposed first andsecond portions extending from opposed ends of a third portion; apositioning feature that is configured to assist with placement of saidmain body with respect to a clavicle of a patient; and first and secondfastening means for securing respective first and second portions ofsaid main body to respective first and second portions of the clavicle,wherein the third portion of said main body extends over a third portionof the clavicle.
 2. The plate of claim 1, wherein the first and secondfastening means comprise respective first and second screw holes definedby respective first and second portions of said main body, said firstand second screw holes being configured to receive respective screwshaving a diameter between 3.5 mm and 4.0 mm.
 3. The plate of claim 1,wherein said main body defines first and second apertures associatedwith anatomical locations of respective first and second ligaments ofthe patient, the first and second apertures being configured to assistwith repairing respective first and second ligaments.
 4. The plate ofclaim 3, wherein the first ligament is a Conoid Ligament and the secondligament is a Trapezoid Ligament and wherein said first and secondapertures are defined by said third portion of said main body.
 5. Theplate of claim 3, wherein each of said first and second apertures isconfigured to interface with a drill guide for assisting with drillingrespective first and second bone tunnels through the clavicle.
 6. Theplate of claim 3, further comprising a first button that is configuredto interface with said first aperture, said first button being moveablebetween a seated configuration and an unseated configuration relative tosaid first aperture, wherein said first aperture and said first buttondefine corresponding interface features.
 7. The plate of claim 6,wherein said corresponding interface features include tapered walls suchthat said first aperture defines opposed top and bottom openings, saidtop opening being larger than said bottom opening.
 8. The plate of claim6, wherein said corresponding interface features include a non-circularshape such that said first button is prevented from rotating relative tothe plate while the first button is in the seated configuration.
 9. Theplate of claim 8, wherein said first button is moved to the seatedconfiguration by moving said first button in a first direction towardsthe clavicle and wherein said corresponding interface features includetapered walls such that movement of said first button in the firstdirection is limited to movement of said first button to the seatedconfiguration.
 10. A clavicle plate for reinforcing a clavicle of apatient, the plate comprising a main body defining first and secondapertures associated with anatomical locations of respective first andsecond ligaments of the patient; a first fixation feature positionedanterior to said first aperture, said first fixation feature beingconfigured so as to facilitate securing a first suture to said mainbody; and a second fixation feature positioned posterior to said secondaperture, said second fixation feature being configured so as tofacilitate securing a second suture to said main body.
 11. The plate ofclaim 13, wherein the first ligament is a Conoid Ligament and the secondligament is a Trapezoid Ligament.
 12. The plate of claim 13, furthercomprising a first button that is configured to interface with saidfirst aperture, said first button being moveable between a seatedconfiguration and an unseated configuration relative to said main body,wherein said first aperture and said first button define correspondinginterface features.
 13. The plate of claim 13, wherein saidcorresponding interface features include tapered walls such that saidfirst aperture defines opposed top and bottom openings, said top openingbeing larger than said bottom opening.
 14. The plate of claim 1, whereinsaid corresponding interface features include a non-circular shape suchthat said first button is prevented from rotating relative to the platewhile the first button is in the seated configuration.
 15. The plate ofclaim 12, wherein said first button is moved to the seated configurationby moving said first button in a first direction towards the clavicleand wherein said corresponding interface features include tapered wallssuch that movement of said first button in the first direction islimited to movement of said first button to the seated configuration.16. A method of treating acromioclavicular joint dislocations, themethod comprising: positioning a main body of a plate relative to aclavicle of a patient; securing a first portion of the main body to afirst portion of the clavicle; and securing a second portion of the mainbody to a second portion of the clavicle, wherein a third portion of themain body extending between the first and second portions of the mainbody extends over a third portion of the clavicle.
 17. The method ofclaim 16, further comprising drilling first and second bone tunnelsthrough the clavicle, the main body defining respective first and secondapertures that are configured to interface with a drill guide forassisting with the drilling step.
 18. The method of claim 17, furthercomprising securing a first suture to a first fixation featureassociated with the main body, the first fixation feature beingdisplaced from the first and second apertures.
 19. The method of claim16, further comprising securing a first suture to a first button, thefirst button and the main body defining corresponding interface featuressuch that the first button is moveable to a seated configuration withrespect to the main body.
 20. The method of claim 19, further comprisingsecuring a second suture to a first fixation feature associated with themain body, the first fixation feature being displaced from the firstbutton.